Doctors Should Only Prescribe Generic Drugs Instead Of Brand-Name Medicines : Plea In Supreme Court

A bench of Chief Justice DY Chandrachud, and Justices JB Pardiwala and Manoj Misra heard the petition filed by transparency activist and environmentalist Kishan Chand Jain under Article 32 of the Constitution. By way of relief, the petitioner seeks strict disciplinary action against medical practitioners who do not adhere to the generic drug prescription mandate under the law, as well as suitable directions to fix maximum retail prices for non-scheduled and generic medicines, conducting surprise checks on prescriptions to ensure compliance, and prohibiting the use of trade names for off-patent drugs, requiring only the manufacturing entity’s name to be displayed.

In this PIL, Jain underscores the economic benefits of generic drugs, which contain the same active ingredients as their branded counterparts but are not tied to a specific brand name, making them notably more affordable. Generic medicines, which have the same therapeutic effects, can cost 50 percent to 90 percent less than branded alternatives. The affordability of generic drugs also helps improve access to essential medications, the petitioner emphasises - 

“Cost is a crucial aspect when it comes to accessing medicines. Generic drugs, which have the same active ingredients as their branded counterparts but are not marketed under a specific brand name, are often significantly cheaper. The prices of generic medicines (off-patented) can be 50% to 90% lower than those of branded medicines. This price difference makes generic drugs more affordable and accessible to a broader section of the population.”

In addition to the price factor, the PIL stresses the urgent need for effective enforcement mechanisms. The petitioner contends that the existing regulations, such as the Indian Medical Council (Professional Conduct, Etiquette, and Ethics) Regulations, 2002, emphasise the importance of prescribing drugs using their generic names.

For example, Clause 1.5 of the regulations requires physicians to prescribe drugs using their generic names, preferably in capital letters. Similarly, to discourage doctors from pursuing profits, Clause 6.3 places a prohibition. A physician is not allowed to run an ‘open shop’ where medicines prescribed by other doctors are sold, or where medical equipment is sold. It is acceptable for a doctor to prescribe or supply medications, remedies, and appliances, as long as patients are not exploited. When a doctor prescribes or acquires medications for a patient, the medicine’s original formula and generic name must be clearly stated. Non-compliance with these regulations amounts to ‘professional or ethical misconduct’.

But, the lack of a robust system to enforce these regulations through disciplinary proceedings, surprise checks of prescriptions, and regular prescription audits has hindered their practical implementation, leaving them confined to legal frameworks. The petitioner argues that the bodies responsible for enforcing these regulations, such as the Ethics and Medical Registration Board (EMRB) and state medical councils, have neglected their duty, leading to adverse consequences for marginalised sections of society and contributing to a healthcare crisis.

Additionally, Jain points out the absence of provisions for setting maximum retail prices (MRP) for non-scheduled formulations, including generic versions of medicines. This absence allows manufacturers unchecked power to establish any MRP, potentially leading to arbitrary pricing regardless of the actual manufacturing cost of the medicine.

The petitioner draws support from a Rajasthan High Court ruling that links the right to affordable medical treatment with Article 21 of the Indian Constitution, which states –

“The right to obtain treatment is tacit of Article 21 of the Constitution of India, and right to obtain treatment at affordable prices of medicines is one of the concomitant of the same. Not prescribing the medicines in generic names may in given facts tantamount to violation of Article 21 of the Constitution of India.”

The petitioner also cites a recent Supreme Court judgment that raised concerns about the manipulation of prescriptions for personal gain, such as receiving gifts and incentives from pharmaceutical companies. Such practices can drive up drug costs, affecting the public negatively by creating a ‘perpetual publicly injurious cycle’.

The petition has been filed through Advocate-on-Record EC Agarwala.

In its latest notification, the National Medical Commission (NMC), has issued new guidelines on professional conduct. One of the stipulations require doctors to avoid prescribing branded generic drugs. Non-compliance might result in penalties or even a suspension of their license to practice for a specified period. The regulations states - 

"Every registered medical practitioner should prescribe drugs using generic names written legibly and prescribe drugs rationally, avoiding unnecessary medications and irrational fixed-dose combination tablets."

Case Details

Kishan Chand Jain v. Ethics and Medical Registration Board and Ors.| Writ Petition (Civil) No. 794 of 2023

Click here to read the order